The Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Phase 4

Completed

• Conditions: Disorder of Bile Duct Stent; Bile Duct Obstruction; Neoplasms
• Interventions: Device: EUS-guided biliary drainage with a hybrid metallic stent

• Registration Number: NCT01862198
• Lead Sponsor: Inje University

Brief Summary

The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Detailed Description

Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-05-19
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-24
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-29
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Age > 20 years
• The presence of an unresectable malignant biliary obstruction
• Failed conventional ERCP stenting

Exclusion Criteria

• Age < 20 years
• An inability to sedate the patient due to advanced heart or pulmonary diseases
• A lack of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hybrid metallic stent	EUS-guided biliary drainage with a hybrid metallic stent	Patients group who were inserted a hybrid metallic stent

Primary Outcome Measures

Name	Time	Method
The stent patency rate	Up to 48 weeks

Secondary Outcome Measures

Name	Time	Method
Patients' survival rate	Up to 48 weeks
Complication rate related to the hybrid stents	Up to 48 weeks

Trial Locations

Locations (2)

Inje University Ilsan Paik Hospital; 🇰🇷 Koyang, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of